上海市普陀区妇婴保健院门诊超说明书用药处方调查与分类管理探索  

Investigation and category management of off-label drug use in the outpatient department prescriptions of Maternity and Child Health Care Center of Putuo District of Shanghai

作　　者：林涛 刘晶晶 LIN Tao;LIU Jingjing(Department of Pharmacy,Maternity and Child Health Care Center of Putuo District of Shanghai,Shanghai 200062,China)

机构地区：[1]上海市普陀区妇婴保健院药剂科

出　　处：《药学服务与研究》2019年第4期309-313,共5页Pharmaceutical Care and Research

摘　　要：目的:了解上海市普陀区妇婴保健院门诊超说明书用药情况,为推动临床合理用药提供依据。方法:抽取2017年7月至12月,每月5日、15日和25日的全样本量门诊处方共计4849张,根据药品说明书判断是否存在超说明书用药,记录超说明书用药处方信息并对涉及药物划分证据等级(Ⅰ~Ⅴ级或无证据)。结果:超说明书用药处方发生率为9.2%,涉及药品23种,超说明书用药32项,主要表现为超适应证用药(88.7%)。出现频率排前三位的药品是雌二醇片/雌二醇地屈孕酮片复合包装、米非司酮片和枸橼酸他莫昔芬片。大部分超说明书用药均有医学证据支持,其中Ⅰ~Ⅱ级证据28项,Ⅲ级证据2项,Ⅴ级证据1项。结论:本院门诊存在超说明书用药情况。药学部门应建立以患者知情同意和循证医学证据为基础的超说明书用药管理办法,从而规避医疗风险,保障临床用药安全。Objective: To investigate the situation of off-label drug use in the Outpatient Department,Maternity and Child Health Care Center of Putuo District of Shanghai,so as to provide reference for promotion of clinical rational use of drugs.Methods:A total of 4849 prescriptions prescribed on the 5th,15th and 25th of each month during the time span from July to December,2017 were selected for the study.Off-label drug use was identified in accordance with the inserted drug directions,the information concerning prescriptions was recorded and evidence levels were graded for the drugs involved (grade Ⅰ-Ⅴ or without evidence).Results:The rate of off-label drug use was 9.2%,involving 23 drug categories,with a total of 32 off-label drug use,mainly displaying in off-indication drug use (88.7%).The top 3 drugs involved in off-label drug use were the complex packing estradiol tablets/estradiol and dydrogesterone tablets,mifepristone tablets and tamoxifen citrate tablets.Most off-label drug use had the support of medical evidences,in which there were 28 with Ⅰ to Ⅱ grades,2 with Ⅲ grade and one with Ⅴ grade.Conclusion:There was off-label drug use in the outpatient of the Center.An off-label drug use management system should be established by the department of pharmacy on the bases of patient knowledge and consent and evidence-based medicine,so as to avoid medical risks and ensure safety of clinical medication.

关 键 词：妇婴保健院 超说明书用药 调查 合理用药 

分 类 号：R969.3[医药卫生—药理学]